Reduction kits

ABSTRACT

The present invention relates to garments and kits, including uses thereof, for providing therapeutic compression such as compression therapy for the treatment of circulatory disorders such as Lymphedema and Venous Disease.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 14/836,653, filed Aug. 26, 2015, which claimspriority to U.S. Provisional Patent Application No. 62/044,921, filedSep. 2, 2014. The contents of these applications are incorporated hereinby reference in their entirety.

TECHNICAL FIELD

The present invention relates to compression therapy garments and kits,including their use.

BACKGROUND

Lymphedema is swelling that occurs when excessive protein-rich lymphfluid accumulates in the interstitial tissue. This lymph fluid maycontain plasma proteins, extravascular blood cells, excess water, andparenchymal products. Lymphedema is one of the most poorly understood,relatively underestimated, and least researched complications of commondiseases like cancer, and thus the prevalence of lymphedema within thegeneral population is largely unknown. Nevertheless, for those who arediagnosed with lymphedema, the standard of care consists of meticulousskin care, manual lymphatic drainage, exercise therapy, inelasticcompression bandaging and, eventually, compression garments.

The frequency and duration of care is dependent on individual subject'stherapeutic need and may range from 2 to 3 visits per week for 6 or moreweeks depending on the severity of lymphedema and any other associatedimpairment.

The use of compression bandaging, although proven effective in reducingedema, has its drawbacks. The application of inelastic compressionbandages is time consuming and requires a skilled clinician.Furthermore, because subjects are not able to effectively bandagethemselves, this treatment strategy does not promote self-care, does notprovide sustained therapeutic levels of compression, and requires thesubject to frequently return for follow up visits. Lastly, wearingbandages negatively impacts the subject's quality of life with regard tocomfort and hygiene which can reduce compliance.

Many bandage alternative wrap type garments exist on the market. Thesegarments are primarily used after the intensive phase treatment oflymphedema to maintain the patient's limb size. Most of the wrapgarments lack the ability to adapt to changes in limb size and are costprohibitive to be used as a short term bandage replacement in theintensive phase. For those garments that are available the sizingadjustments can be complex and time consuming for practical use.

The embodiments of the present disclosure address these and otherrelated needs in the art.

SUMMARY

In certain embodiments a compression garment is provided, comprising: abody dimensioned to wrap at least partially around a length of a limb ofa subject, wherein the body has an adjustable length; a plurality oftrimmable tension bands positioned along the adjustable length of thebody; a limb positioning sleeve positioned on the body and/or tensionbands; and a plurality of removable fasteners for attachment onto thebody or tension bands. The limb positioning sleeve can be a guidesleeve.

In frequent embodiments each of the plurality of fasteners comprises ahook and/or loop fastener. In other embodiments, one or more of thefasteners comprises a hook and loop fastener. Frequently, the fastenercomprises a hook fastener. Often, a number of the plurality of removablefasteners corresponds to a number of the plurality of trimmable tensionbands. Also, often each of the plurality of removable fasteners attachesan extension band onto the body or one of the plurality of trimmabletension bands.

In certain embodiments the body and the trimmable tension bands arecomprised of a single contiguous piece of material or laminate. Often,the contiguous piece of material is permeable to fluids.

In frequent embodiments, a number or each of the tension bands comprisesmeasurement indicia that provides an indication of tension in ordisplacement of the corresponding tension band.

Often, the compression garment is customizable to be sized to fit asubject by adjusting the adjustable length of the body and/or trimmingany of the trimmable tension bands to remove excess material whenwrapped around the limb of the subject.

In certain frequent embodiments, the limb positioning sleeve comprises aflap having a first end affixed to the body or the tension band, and asecond end that is removably attachable onto the flap, the body, thetension band, or a second flap affixed to the body or the tension band.Often, the limb positioning sleeve comprises a first flap and a secondflap, wherein the first and second flap are removably attached orattachable onto one-another. Also often, the limb positioning sleevecomprises a first flap and a second flap, each flap having a respectivefirst end affixed to the body or the tension band, wherein the first andsecond flap are removably attached or attachable to one-another.

Frequently, the compression garment comprises an adjustable length ofthe body that is adjusted by removing a portion of the adjustable lengthof the body. Often, a portion of a trimmable tension band, or an entiretrimmable tension band, is removed by adjusting the length of the body.Guide indicia are often provided to show where the body or bands shouldbe cut. Also, the adjustable length of the body is often adjusted byremoving a portion of the adjustable length of the body and at least aportion of one or more of the plurality of trimmable tension bands. Alsofrequently, the adjustable length of the body is adjusted by removing aportion of the adjustable length of the body and one or more of theplurality of trimmable tension bands.

In frequent embodiments, one or more of the plurality of trimmabletension bands is trimmed to remove a portion of a length of thetrimmable band to produce a plurality of trimmed bands when or after itis wrapped around the limb of a subject. Often, each of the removablefasteners is attached to an associated/respective end of each of thetrimmable tension bands. In certain frequent embodiments, at least about75% of the plurality of trimmable tension bands have the same width.Often, at least about 85% of the plurality of trimmable tension bandshave the same width.

Each of the plurality of trimmable tension bands most frequentlycomprises a solid contiguous material or laminate. Often, at least oneof the plurality of trimmable tension bands comprises multiple materialshaving differing material properties.

In certain embodiments, the body comprises two or more detachablepieces. In such embodiments, often the two or more detachable pieces arepositionable at positions onto each piece opposed to a respectiveposition of the trimmable tension bands.

Frequently, the compression garment comprises an arm wrap reduction kitor a leg wrap reduction kit. Often, the compression garment comprises afoot or hand wrap reduction kit.

Methods of using the reduction kits of the present disclosure. Often amethod of using the compression of garment of the present disclosure isprovided, comprising positioning a limb of a subject in the limbpositioning sleeve, applying tension to each of the plurality oftrimmable tension bands to provide a predetermined level of compressionto the limb, and attaching a removable fastener to each of the pluralityof trimmable tension bands to fasten the band at the predetermined levelof compression. Frequently, the method further comprises removing aportion of one or more of the plurality of trimmable tension bands.Often, the pre-determined level of compression is obtained using anassured tension measuring system. Also, frequently, the subject performseach step of the claimed method without the aid of a clinician oranother person.

Methods are also provided, similar to the above, whereby the subjectcontinues to remove portions of one or more of the plurality oftrimmable tension bands over time as a level of lymphedema decreases inthe subject.

Methods of manufacturing the garments described herein (e.g., a footwrap, a hand wrap, an arm wrap, a leg wrap, etc.) are also contemplatedsuch that a compression garment is manufactured comprising a singlecontiguous piece of material such as fabric having a known orpredetermined elasticity profile. These garments are manufactured to bespecifically fitted to a specific limb of a subject. Such garments areoften trimmable garments, optionally including one or more removablefasteners, as further described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts one exemplary embodiment of an arm wrap of the presentdisclosure.

FIG. 2 depicts another exemplary embodiment of an arm wrap of thepresent disclosure.

FIG. 3 depicts one exemplary embodiment of a foot wrap of the presentdisclosure positioned adjacent to a foot for illustrative purposes.

FIG. 4 depicts one exemplary embodiment of a hand wrap of the presentdisclosure.

DETAILED DESCRIPTION

Unless defined otherwise, all terms of art, notations and otherscientific terms or terminology used herein have the same meaning as iscommonly understood by one of ordinary skill in the art to which thisinvention belongs. In some cases, terms with commonly understoodmeanings are defined herein for clarity and/or for ready reference, andthe inclusion of such definitions herein should not necessarily beconstrued to represent a substantial difference over what is generallyunderstood in the art. All patents, applications, published applicationsand other publications referred to herein are incorporated by referencein their entirety. If a definition set forth in this section is contraryto or otherwise inconsistent with a definition set forth in the patents,applications, published applications and other publications that areherein incorporated by reference, the definition set forth in thissection prevails over the definition that is incorporated herein byreference.

As used herein, “a” or “an” means “at least one” or “one or more.”

As used herein, the term “subject” is not limited to a specific species.For example, the term “subject” may refer to a patient, and frequently ahuman patient. However, this term is not limited to humans and thusencompasses a variety of mammalian species.

As used herein, “reduction kit” refers to any of a variety of single orcontiguous material, one-size-fits-all compression modules or garmentsspecific to a specific limb or portion thereof, or other part of asubject's body, comprised of inelastic material that is easilyadjustable.

In certain embodiments a reduction kit of the present disclosurecomprises a one-size-fits-all, easy-to-use, inelastic, instantlyadjustable compression bandage module that is fitted to a subject's limbin a medical clinic and/or by a medical professional. In the mostfrequent embodiments, reduction kits of the present disclosure comprisea single contiguous piece of material designed, cut, and adapted to fitand provide therapeutic compression to a particular part or region of asubject. The term “contiguous” is used herein to refer to a singlematerial or co-extensive laminate of materials. Materials that arecomprised of partially overlapping and non-coextensive layers, or arecomprised of materials/sheets that are attached end-to-end are notconsidered to be a single contiguous material as that term is usedherein.

Such kits need only be trimmed and attached using fasteners to provide acustomized fit to all subjects. In particularly frequent embodiments,the kits also include a guide sleeve as further described below anddepicted herein.

These reduction kits often comprise upper or lower extremity wraps andare made of breathable material that has sufficient elasticity to followthe contour of the limb and thickness to bridge skin folds, maximizingcomfort and reducing slippage. Certain exemplary materials include, forexample, BREATH-O-PRENE® material (available from Accu-Med Technologies,Inc., Buffalo, N.Y.). Such materials have surfaces that are oftenuseable with hook fasteners that attach directly to the garment, withoutthe use of a specific loop material to work in conjunction with the hookfastener.

In certain embodiments, a reduction kit of the present disclosurecomprises a body and a series of juxtaposed bands that are wrappedaround the limb and fastened with hook and loop closures, which allowsfor quick and easy application, as well as removal and adjustment of thegarment. Once first applied by the clinician or the like, a subject canoften thereafter easily and quickly apply the reduction kit consistentlyat a pre-determined compression level (which can be adjusted) withoutassistance from a clinician. This ease of use increases compliance andhygiene, which greatly improves the therapeutic effect of the use of thereduction kit with far fewer follow-up sessions. In certain frequentembodiments, the reduction kit also features an assured tensionmeasuring system, which ensures the patient can sustain the samecompression as applied by the clinician. See, for example, U.S. Pat.Nos. 6,338,723 and 7,329,232, each of which is incorporated herein byreference.

The quick, simple and therapeutic application of the reduction kitcombines to give the subject a comfortable, clean and effective systemthat will not unduly hinder their lifestyle or state of mind whileeffectively delivering therapeutic compression and, for example,managing edema.

Arm Wrap

In certain embodiments, an arm wrap reduction kit is provided having abody I as a flat piece of fabric with a series of juxtaposed bands 14designed to cover the arm of a subject from the subject's wrist to theaxilla. The bands 14 are designed to be wrapped around the arm andtightened to provide compression and are attached to the body 20 or backunto themselves with, for example, hook and loop fastener tabs, e.g.,hook tabs 17. The hook tabs 17 are often kept separate, or are otherwisepositioned on the kit or unattached to the kit while sizing so thelength L_(C) of the band, e.g., band 14, can be trimmed to the lengththat best fits the limb of the specific subject. Frequently, the lengthL_(C) is longer than the width of the body 20 portion in that region sothat a larger range of limb circumferences can be accommodated.Additionally, in certain embodiments, a portion of the body 20 and oneor more bands 14 may be removed from the garment to reduce the overalllength L_(L). in order to fit the limbs of certain subjects. In frequentembodiments, indicia or cut marks 16 are present on the garment to guidethe trimming and fitting of the kit to the correct size. Indicia or cutmarks 16 refer to an indication on the kit to guide removal of portionsof the body 18, portions of bands and/or entire bands 14.

In frequent embodiments, the arm wrap reduction kit also includes alateral rise 15 that is provided to apply compression to the subject bythe reduction kit beyond the end of the sleeve or body 18 further up thelimb, for example, laterally beyond an outermost band 14 to reachadditional areas of the subject such as past the axilla onto theshoulder. In leg garment versions, this lateral rise 15 coverage areaoptionally extends above the groin onto the thigh.

Given that the user only has one arm available to tighten and apply thebands, it is often beneficial to incorporate a guide sleeve, for exampletwo or more guide sleeves 13 in FIG. 2 to hold the body 18 and bands 14in position on the limb of the subject prior to tightening and/or whilebeing tightened. Guide sleeves are often beneficial on arm wrapembodiments of the present disclosure, but may be provided on otherembodiments such as leg, foot, hand wraps, or the like. In variousembodiments, there may be one or more of these sleeves as needed on thereduction kit.

Frequently the disclosed guide sleeves are trimmable or trimmed to alength that optimizes their fit on a specific subject. In frequentembodiments, these sleeves are secured with fastener tabs (e.g., hookand/or loop tabs). FIG. 2 depicts two guide sleeves 13, one in a closedorientation, and the other (closer to the lateral rise) in an openorientation. As can be seen in the open orientation, the guide sleevemay comprise two flaps, either or both of which can be trimmed to ashorter length and the two ends can be removably attached with afastener tab.

In certain embodiments, one of the flaps of the guide sleeve 13 is nottrimmable and comprises an attached fastener (e.g., a hook and/or loopfastener), to fasten it to the other flap, which may be trimmable. Theopposite ends of the flaps that are not trimmed or trimmable are oftenattached in a permanent, semi-permanent, or removable manner to the bodyof the reduction kit.

Although exemplary guide sleeves depicted herein are provided in a dualflap arrangement, other embodiments of guide sleeves useable with thepresent reduction kits include, for example, a tube attached orattachable to the body of the garment that the subject may use bysliding the tube over a specific limb. A variety of other configurationsand orientations are contemplated.

Foot Wrap:

An exemplary embodiment of a foot wrap reduction kit is depicted in FIG.3. This foot wrap includes, for example, trim indicia or markings 16 toguide the user to the proper fit. Though not wishing to be bound bytheory, the wrap is intended to cover and apply compression to key areasof the foot such as the arch and below the malleoli. Additionalcompression to other areas of the foot is often applied via acompression anklet, compression stocking, or another garment or device.

In certain embodiment, to apply the foot wrap, tab 12 is held by asubject or clinician in one hand while the arch band 10 is wrappedaround the arch of the foot and secured back unto itself with separateVelcro hook tab 17. The heel band 11 is then wrapped over the malleolibehind the foot around the achilles and attached onto the arch band 11.The foot length fit L_(L). can be adjusted by trimming the arch band,for example, along dotted line 16. The arch circumference L_(C) fit canbe adjusted, for example, by trimming the length of the arch band 10,for example, along dotted line 16. The placement of the arch band 10towards or away from the toes can be adjusted, for example, by trimmingthe heel band 11 length L_(Y), for example, along dotted line 16.

Hand Wrap:

Frequent embodiments of the hand wrap reduction kit 24 are intended tocover the hand of a subject, from near the base of the fingers to thewrist. The hand wrap consists of a series of juxtaposed bands similar tothe arm wrap 18, but also including a thumb hole 26 to anchor the wrapin place on the subject's thumb. In use of such embodiments, the palmand fingers of the subject can be covered, for example, by wrapping band21 around the hand and attaching it back onto itself via hook tab 17.Band 22 can be similarly applied and covers, for example, the back ofthe hand starting at the thumb. Band 23, in frequent embodiments,continues to cover the wrist area and may be shorter or extended longerto cover further up the subject's arm in a bandaging fashion. Thegarment may include a dart 25 or multiple darts to better conform to thecurvature of the subject's limb. In the most frequent embodiments,indicia and markings 16 are present to aid in guiding trimming andsizing of the hand wrap. The bands can be trimmed, for example, to besized to smaller circumferences. In addition, in certain embodiments thewrap length L_(H) can be shortened to cover more or less of the hand andfingers.

With regard to each of the embodiments described here, most frequentlyeach is comprised of a single contiguous piece of material (e.g.,fabric), often with a known or pre-determined elasticity profile. Thesingle piece of material garment is often provided with indicators fortension application (e.g., compression indicators) on a specific portionof the limb (e.g., different levels of compression may be applied to asingle limb) or on the limb overall. Often, a guide sleeve is includedor formed on the garment to aid in accurate placement of the garment ona limb without the need for assistance of another person or health careprofessional. Moreover, most frequently, the single contiguous piece ofmaterial is adapted to be trimmed to remove portions of the materialthat aid in fitting a single size of the garment to a subject,regardless of the specific size of the limb of the subject. Mostfrequently, the body and/or a band may be trimmed to remove material,for example as depicted and explained herein. As is known in the art,limb size varies between subjects. Also, as therapy progresses for aspecific subject, their limb size often changes such as getting smallerfor example due to decreased lymphedema induced limb swelling. There area variety of advantages that have been discovered by the inventors aspart of this innovation as noted herein, as well as for ease inmanufacturing of garments in a single size that fits different subjectshaving different sized limbs. Less occasionally, 2 or 3 sizes areprovided that are adjustable or trimmable to fit a full range of limbsizes. Removable tabs are often provided to aid in accurate placement ofthe garment before or after trimming.

Other features and advantages of the invention will be apparent from thedescription herein. The examples are provided herein are solely toillustrate the invention by reference to specific embodiments. Theseexemplifications, while illustrating certain specific aspects of theinvention, do not portray the limitations or circumscribe the scope ofthe disclosed invention. Many variations to those described above arepossible.

We claim:
 1. A compression garment, comprising: a body dimensioned towrap at least partially around a length of a limb of a subject definedby a length; a plurality of tension bands extending from the body in adirection that is perpendicular to the length of the body positionedalong the adjustable length of the body, each band of the plurality oftension bands having a band width and a band length; wherein theplurality of tension bands are configured to be wrapped around the limbof the subject and tightened to provide compression to the limb; a limbpositioning sleeve configured to hold the body and the plurality oftension bands on the limb of the subject prior to or during tightening,the limb positioning sleeve positioned on the body and/or tension bandscomprising a first flap and a second flap, each having a respectivefirst end affixed to the body at an attachment position, wherein thesecond end of the first flap is removably attachable to the second endof the second flap, wherein the first and second flaps are dimensionedto have a sleeve width that is smaller than the length of the body atleast at the attachment position, and wherein the sleeve width issmaller than the band width of each of the plurality of tension bands;and a plurality of fasteners for attachment onto the body or tensionbands, wherein when each of the plurality of trimmable tension bands iswrapped around the limb of the subject and tightened to providecompression to the limb.
 2. The compression garment of claim 1, whereinthe body and the plurality of tension bands are comprised of a singlecontiguous piece of material or laminate.
 3. The compression garment ofclaim 1, wherein one or more of the plurality of tension bands comprisesa measurement indicia that provides an indication of tension in ordisplacement of the corresponding tension band.
 4. The compressiongarment of claim 1, wherein the length of the body is adjustable byremoving a portion of the length of the body.
 5. The compression garmentof claim 1, wherein the length of the body is adjusted by removing aportion of the length of the body and at least a portion of one or moreof the plurality of tension bands.
 6. The compression garment of claim1, wherein at least about 75% of the plurality of tension bands have thesame width.
 7. The compression garment of claim 1, wherein at least oneof the plurality of tension bands comprises multiple materials havingdiffering material properties.
 8. The compression garment of claim 1,wherein the body comprises two or more detachable pieces.
 9. Thecompression garment of claim 8, wherein the two or more detachablepieces are positionable at positions onto each piece opposed to arespective position of the plurality of tension bands.
 10. A method ofusing the compression of garment of claim 1, comprising positioning alimb of a subject in the limb positioning sleeve, applying tension toeach of the plurality of tension bands to provide a predetermined levelof compression to the limb, and attaching each of the plurality oftension bands to the body or a portion of the respective tension band oranother of the plurality of tension bands at the predetermined level ofcompression.
 11. The method of claim 10, further comprising removing aportion of one or more of the plurality of tension bands.
 12. The methodof claim 10, wherein the pre-determined level of compression is obtainedusing an assured tension measuring system.
 13. The method of any ofclaim 10, wherein the subject performs each step of the claimed methodwithout the aid of a clinician or another person.
 14. The method of anyof claim 10, wherein the subject continues to remove portions of one ormore of the plurality of trimmable tension bands over time as a level oflymphedema decreases in the subject.
 15. A compression garment,comprising: a body dimensioned to wrap at least around a leg at the kneeregion of a subject, the body defined by a length; a plurality oftension bands extending from the body in a direction that isperpendicular to the length of the body and positioned along the lengthof the body, wherein each band of the plurality of tension bands isdefined by a band width and a band length; wherein each of the pluralityof tension bands is configured to be wrapped around the leg of thesubject and tightened to provide compression to the leg at the kneeregion of the subject; and a positioning sleeve configured to hold thebody on the leg of the subject prior to or during tightening, whereinthe positioning sleeve positioned on the body comprises at least oneflap affixed to the body at an attachment position and the positioningsleeve is defined by a positioning sleeve width, the positioning sleevewidth being smaller than the length of the body at least at theattachment position, and the positioning sleeve further comprises aplurality of fasteners, with the positioning sleeve featuring a fastenerpositioned at both a top and a bottom of the sleeve width.
 16. Acompression garment, comprising: a body dimensioned to wrap at leastaround a leg at the knee region of a subject, the body defined by alength; a plurality of tension bands extending from the body in adirection that is perpendicular to the length of the body and positionedalong the length of the body, each band of the plurality of tensionbands having a band width and a band length; wherein the plurality oftension bands are configured to be wrapped around the leg of the subjectand tightened to provide compression to the leg at the knee region; anda positioning sleeve configured to hold the body on the leg of thesubject prior to or during tightening, the positioning sleeve positionedon the body comprising a first flap and a second flap, each having arespective first end affixed to the body at an attachment position,wherein a second end of the first flap is removably attachable to asecond end of the second flap, wherein the first and second flaps aredimensioned to have a sleeve width that is smaller than the length ofthe body at least at the attachment position.
 17. The compressiongarment of claim 16, further comprising one or more fastener forremovably attaching the second end of the first flap to the second endof the second flap.
 18. The compression garment of claim 15, wherein thebody and the tension bands are comprised of a single contiguous piece ofmaterial or laminate.
 19. The compression garment of claim 15, whereinone or more of the tension bands comprises measurement indicia thatprovides an indication of tension in or displacement of thecorresponding tension band.
 20. The compression garment of claim 15,further comprising a fastener attached to one or more of the pluralityof tension bands.